Investigation of the Effects of Medium Cut-off Dialyzers Versus High-Flux Dialyzers on Clinical and Laboratory Parameters of Prevalent Hemodialysis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2020-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In this study, the investigators aimed to observe the effects of medium cut-off dialysis filters and high-flux dialysis filters on malnutrition inflammation score, uremic itching, restless leg syndrome, anemia, and ESA treatment, which are prominent complications in hemodialysis, and routine follow-up parameters.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Comparative Study of Two Kinds of Hemodialysis Filters

NCT05899283

Uremia

COMPLETED NA

Effect of Dialysis Membranes on Inflammatory and Immune Processes in Hemodialysis

NCT03836508

Kidney Failure Renal Insufficiency, Chronic Dialysis Related Complication

COMPLETED NA

Investigation of the Effect of Intradialytic Exercise on Functional Capacity,Quality of Life in Hemodialysis Patients

NCT05246956

Renal Disease

UNKNOWN NA

Comparison of Four and Eight Hours Dialysis Sessions in Thrice Weekly Hemodialysis

NCT00413803

End-Stage Renal Disease Hemodialysis

COMPLETED PHASE4

The Effect and Safety of Hemodialysis and Hemoperfusion on Severe Renal Osteopathy and Itching in Uremia Patients

NCT02747979

Hyperparathyroidism Refractory Pruritus Ostalgia +1 more

COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study is designed as a single-center, prospective, observational research. A total of 50 stable-course chronic hemodialysis patients over 18 years of age and treated for at least 3 months will be included in the study and the study period will be planned for 12 months. 25 of the 50 chronic hemodialysis patients planned to be included in the study will use MCO-membrane and the other 25 will use high-flux membrane. The distribution of patients to the high-flux membrane and MCO membrane groups will be done randomly (sequentially single-pair number method). Then, the standard 12-hour (3x4 hours/week) hemodialysis treatment will continue. At the beginning of the study (0.), at the end of the third (3.) month and at the end of the sixth (6.) month;

Monthly laboratory tests routinely performed on hemodialysis patients (tests routinely performed in hemodialysis patient follow-up) 5 ml blood samples will be taken from the hemodialysis set to determine the levels of medium-large molecule-weight toxins-wastes and inflammatory parameters before and after dialysis, and the sera will be separated and stored at -80oC for use at the end of the study.

Automatic blood pressure measurement will be performed before and after hemodialysis to evaluate arterial stiffness.

The Malnutrition Inflammation Score will be applied to evaluate the nutritional status (the MIS form is given in the appendix) Visual Analog Scale will be used for appetite Visual Analog Scale will be used for uremic pruritus Depression scale screening (Beck's scale)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hemodialysis-Associated Pruritus Malnutrition-Inflammation-Cachexia Syndrome Restless Legs Syndrome Anemia of Chronic Kidney Disease Depressive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

The Theranova 400 group, also known as the MCO group.

Patients undergoing maintenance hemodialysis will receive dialysis treatment using the Theranova 400 device.

Dialysis using the Theranova-400 device.

Intervention Type DEVICE

Patients receive hemodialysis treatment using the Theranova-400 dialyzer.

The FX80 group, also known as the high-flux group.

Patients undergoing maintenance hemodialysis will receive dialysis treatment using the FX80 device.

Dialysis using the FX80 device.

Intervention Type DEVICE

Patients receive hemodialysis treatment using the FX80 dialyzer.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dialysis using the Theranova-400 device.

Patients receive hemodialysis treatment using the Theranova-400 dialyzer.

Intervention Type DEVICE

Dialysis using the FX80 device.

Patients receive hemodialysis treatment using the FX80 dialyzer.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Chronic hemodialysis patients
* Patients continuing the hemodialysis program for at least 3 months
* Patients over 18 years of age

Exclusion Criteria

* Patients with advanced heart failure, malignancy, terminal illness
* Patients with active infectious disease
* Acute hemodialysis patients
* Patients vascular access dysfunction

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No